Self-collected Swabs for HPV Testing in 18-24 Year Old Women (DRY)

This study has been completed.
Sponsor:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01101828
First received: April 7, 2010
Last updated: February 10, 2011
Last verified: February 2011
  Purpose

The purpose of this study is to compare methods for transporting self-collected swabs for HPV testing in 18-24 year old women and to look at risk factors for HPV infection in 18-24 year old women.


Condition
Papillomavirus Infections

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Self-collected Swabs for HPV Testing in 18-24 Year Old Women

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Presence of type-specific HPV DNA in self-collected vaginal swab samples [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Self-collected vaginal samples for HPV testing


Estimated Enrollment: 150
Study Start Date: April 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Detailed Description:

We propose a cross-sectional study among 150 women in the United States who have used Internet dating sites in the past year in order to examine risk factors for high-risk HPV infections in 18-24 year old online daters, and evaluate strategies for transporting and storing self-collected samples for HPV testing. We will ask participants to complete a written questionnaire on their health, sexual behavior, and attitudes toward self-collecting vaginal swabs, HPV vaccination, and cervical cancer screening. Also, we will ask the women to self-collect two sequential vaginal swab samples that will be transported and stored according to the two strategies described above. Each sample will be tested for type-specific HPV DNA using a PCR-based assay.

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

18 to 24 year old women who date online

Criteria

Inclusion Criteria:

  • Have had sex with men
  • Have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website)

Exclusion Criteria:

  • Pregnant or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101828

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Rachel L Winer, PhD, MPH University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: Rachel L. Winer/Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01101828     History of Changes
Other Study ID Numbers: 37822-A
Study First Received: April 7, 2010
Last Updated: February 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014